PMID- 20164251
OWN - NLM
STAT- MEDLINE
DCOM- 20100615
LR  - 20211020
IS  - 1556-679X (Electronic)
IS  - 1556-6811 (Print)
IS  - 1556-679X (Linking)
VI  - 17
IP  - 4
DP  - 2010 Apr
TI  - Randomized trial on the safety, tolerability, and immunogenicity of MenACWY-CRM, 
      an investigational quadrivalent meningococcal glycoconjugate vaccine, 
      administered concomitantly with a combined tetanus, reduced diphtheria, and 
      acellular pertussis vaccine in adolescents and young adults.
PG  - 537-44
LID - 10.1128/CVI.00436-09 [doi]
AB  - This study evaluated the safety, tolerability, and immunogenicity of an 
      investigational quadrivalent meningococcal conjugate vaccine, MenACWY-CRM, when 
      administered concomitantly with a combined tetanus, reduced diphtheria, and 
      acellular pertussis (Tdap) vaccine, in subjects aged 11 to 25 years. Subjects 
      received either MenACWY-CRM and Tdap, MenACWY-CRM and saline placebo, or Tdap and 
      saline placebo. No significant increase in reactogenicity and no clinically 
      significant vaccine-related adverse events (AEs) occurred when MenACWY-CRM and 
      Tdap were administered concomitantly. Similar immunogenic responses to 
      diphtheria, tetanus, and meningococcal (serogroups A, C, W-135, and Y) antigens 
      were observed, regardless of concomitant vaccine administration. Antipertussis 
      antibody responses were comparable between vaccine groups for filamentous 
      hemagglutinin and were slightly lower, although not clinically significantly, for 
      pertussis toxoid and pertactin when the two vaccines were administered 
      concomitantly. These results indicate that the investigational MenACWY-CRM 
      vaccine is well tolerated and immunogenic and that it can be coadministered with 
      Tdap to adolescents and young adults.
FAU - Gasparini, Roberto
AU  - Gasparini R
AD  - Department of Health Sciences, University of Genoa, Via Pastore 1, 16132 Genoa, 
      Italy. gasparini@unige.it
FAU - Conversano, Michele
AU  - Conversano M
FAU - Bona, Gianni
AU  - Bona G
FAU - Gabutti, Giovanni
AU  - Gabutti G
FAU - Anemona, Alessandra
AU  - Anemona A
FAU - Dull, Peter M
AU  - Dull PM
FAU - Ceddia, Francesca
AU  - Ceddia F
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100217
PL  - United States
TA  - Clin Vaccine Immunol
JT  - Clinical and vaccine immunology : CVI
JID - 101252125
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Diphtheria-Tetanus-acellular Pertussis Vaccines)
RN  - 0 (MenACWY)
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Placebos)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Bacterial/blood
MH  - Child
MH  - Diphtheria-Tetanus-acellular Pertussis Vaccines/administration & dosage/*adverse 
      effects/*immunology
MH  - Female
MH  - Humans
MH  - Male
MH  - Meningococcal Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Placebos/administration & dosage
MH  - Vaccines, Conjugate/administration & dosage/adverse effects/immunology
MH  - Young Adult
PMC - PMC2849330
EDAT- 2010/02/19 06:00
MHDA- 2010/06/16 06:00
PMCR- 2010/10/01
CRDT- 2010/02/19 06:00
PHST- 2010/02/19 06:00 [entrez]
PHST- 2010/02/19 06:00 [pubmed]
PHST- 2010/06/16 06:00 [medline]
PHST- 2010/10/01 00:00 [pmc-release]
AID - CVI.00436-09 [pii]
AID - 0436-09 [pii]
AID - 10.1128/CVI.00436-09 [doi]
PST - ppublish
SO  - Clin Vaccine Immunol. 2010 Apr;17(4):537-44. doi: 10.1128/CVI.00436-09. Epub 2010 
      Feb 17.